| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 13:30:49 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7. Evaluation of overall residual risk acceptability |
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Overview- Organisation Chart
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Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- ISO 14971 Requirements
- 2 Terms an definitions
- 3. General requirements for risk management
- 4. Risk analysis
- 5. Risk evaluation
- 6. Risk control
- 7. Evaluation of overall residual risk acceptability
7. Evaluation of overall residual risk acceptability
«Functional» 7 Decide if the overall residual risk is acceptable using the criteria defined- «Functional» 7 Gather and review data and literature ir the overall residual risk is not judged acceptable
- «Functional» 7 Decide which information is necessary to include in the accompanying documents for an overall risk that is judged acceptable
- 8. Risk management report
- 9. Production and post-production information
- Anhang ZA
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox